MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-06-09 for C.R.E. BALLOON DILATION CATHETER M00558380 manufactured by Boston Scientific.
[20771010]
It was reported that during an esophageal balloon dilation treatment procedure, the balloon deflation failed. A cre 18-20mm 8cm f/g balloon dilation catheter had been selected to treat an unspecified esophageal lesion. While the physician was attempting to advance the device, the device kinked and would not pass through the scope adequately. A second cre 18-20mm 8cm f/g balloon dilation catheter was advanced and inflated, but would not deflate. The device was able "to be pulled out with the scope and cut". The procedure was completed with another cre 18-20mm 8cm f/g balloon dilation catheter. There was no pt complications reported with the pt's current condition listed as "fine".
Patient Sequence No: 1, Text Type: D, B5
[20808833]
The complaint description could not be confirmed as the complaint sample was not returned. The device history record for the lot number has been reviewed for manufacturing issues and no issues or discrepancies were found which could relate to this complaint. The device history record review confirms that this device met all material, assembly and performance specifications. The root cause will be classified as undeterminable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-00660 |
| MDR Report Key | 1122784 |
| Report Source | 05,07 |
| Date Received | 2008-06-09 |
| Date of Report | 2008-05-14 |
| Date of Event | 2008-05-09 |
| Date Mfgr Received | 2008-05-14 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2008-10-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEN HIRAKAWA |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836264 |
| Manufacturer G1 | BOSTON SCIENTIFIC |
| Manufacturer Street | CORK BUSINESS & TECHNOLOGY PK MODEL FARM RD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C.R.E. BALLOON DILATION CATHETER |
| Generic Name | KNG DILATOR, ESOPHAGEAL |
| Product Code | KNG |
| Date Received | 2008-06-09 |
| Catalog Number | M00558380 |
| Lot Number | 9762664 |
| Device Expiration Date | 2009-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1259805 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-09 |